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Completed

NCT Number: NCT02471053

Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study

As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are becoming increasingly apparent. Most prominent are the toxic effects on the heart (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular disease (CVD). The investigators hypothesize that an individualized aerobic training program for cancer patients receiving active treatment will be both feasible and safe and will result in improvements in overall levels of physical activity and quality of life.

Feasibility will be assessed by evaluating the recruitment, adherence and attrition rates, along with program safety. Efficacy will be assessed by evaluating changes in health-related outcomes.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QEII Health Science Center, Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

About this study

As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are becoming increasingly apparent. Most prominent are the toxic effects on the heart (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular disease (CVD). Of note, data indicate that the magnitude of CVD risk for long-term survivors may exceed the risk of a secondary malignancy, which is a known complication of primary cancer therapy. While long-term follow-up data in adult cancer survivors is lacking, study of adult survivors of childhood cancers shows that these individuals are 15 times more likely to develop congestive heart failure (CHF), 10 times more likely to develop CVD, and 9 times more likely to suffer a stroke compared individuals who have not had cancer. Thus, it is clear that the long-term cardiotoxic effects of cancer therapy represent a significant concern for cancer survivors. The mechanisms responsible for the damaging effects of cancer therapy are not fully understood, however there is a need to maximize the benefits of treatment while minimizing long-term damage. Recent animal studies suggest that aerobic exercise training may offer a protective effect against chemotherapy-induced heart disease. However, to the investigator's knowledge, no study to date has examined the potential cardioprotective benefits of exercise training for patients receiving cancer treatment.

Accordingly, the purpose of this pilot study is to evaluate the feasibility and efficacy of a 12-week supervised exercise program based on the principles of cardiac rehabilitation for patients receiving anthracycline-based chemotherapy.

Feasibility will be assessed by evaluating three outcomes, recruitment rate, adherence rate (i.e. exercise class attendance records), attrition rate, and safety (i.e. number of adverse events).

Efficacy will be assessed by evaluating changes in health-related outcomes to assess if these changes are equal to or better than what was measured at baseline. The health-related outcomes include cardiac function and biological markers of cardiotoxicity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Only those patients who meet the following inclusion will be asked to participate in the study:

  • Between the ages of 18 and 65;
  • Receiving anthracycline chemotherapeutic treatment for a primary/non-recurrent breast or hematological malignancy;
  • Are scheduled to received a minimum dose of 100 mg/m2 of doxorubicin (DOX) or 120 mg/m2 of daunorubicin (DAUN), or 150 mg/m2 epirubicin (EPI)
  • Within eight weeks of first anthracycline dose;
  • Do not have a previous history of myocardial infarction, cerebrovascular disease, peripheral vascular disease, congestive heart failure, or cardiomyopathy (controlled hypertension is not exclusionary);
  • Have no known contraindications to light-to-moderate exercise;
  • Have no known contraindications to cardiopulmonary exercise stress testing;
  • Able to participate in the 12-week community-based exercise program;
  • Provided medical consent from their treating physician

Exclusion criteria

  • Any patients who meet the inclusion criteria, but have any significant cognitive limitations will be excluded from the study.

Treatment and study plan

Moderate Intensity Exercise

Other

Exercise sessions will be held twice-weekly and will begin with a group warm-up activity, followed by 45 minutes of aerobic activity and ending with a cool down. All aerobic exercise will be performed at a moderate intensity, defined as exercise that elicits a heart rate (HR) between 40-60% of heart rate reserve (HRR). Prior to the initial exercise session target heart rates will be calculated for each subject based on the maximum HR achieved during their baseline stress test.

Primary outcomes

  1. Feasibility as measured by rate of recruitment

    Time frame: 12 Weeks

    The rate of recruitment will be measured by comparing the number of patients screened to the number of patients enrolled (patients per month).

  2. Number of adverse events

    Time frame: 12 Weeks

    The number of adverse events associated with exercise program will be used to examine safety.

Secondary outcomes

  1. Feasibility as measured by program adherence

    Time frame: 12 Weeks

    The program adherence will be calculated by dividing the total number of exercise sessions by the number of actual session attended.

  2. Feasibility as measured by attrition rate

    Time frame: 12 Weeks

    The attrition rate will be measured by the number of patients who drop out of the study.

  3. Cardiac Function

    Time frame: 12 Weeks

    Cardiac function will be measured by examining heart chamber size, ventricular function and blood flow between the cardiac chambers using a Multigated acquisition (MUGA) scan.

  4. Cardiac Disease Risk

    Time frame: 12 Weeks

    Cardiac disease risk will be measured using the Framingham Risk Score.

  5. Aerobic Fitness

    Time frame: 12 Weeks

    Aerobic fitness will be measured by comparing baseline and 12 week cardiac stress tests and the associated peak oxygen uptake values.

  6. Fatigue

    Time frame: 12 Weeks

    The Functional Assessment of Cancer Therapy - Fatigue questionnaire will be used to compare baseline and 12 week self-reported levels of fatigue.

  7. Physical Activity Behaviours

    Time frame: 12 Weeks

    Baseline and 12 week levels of physical activity will be measured using the International Physical Activity Questionnaire.

  8. Life Quality

    Time frame: 12 Weeks

    The Functional Assessment of Cancer Therapy - General questionnaire along with the appropriate tumor specific appendix, will be used to compare baseline and 12 week quality of life measures.

  9. Lipid Profile

    Time frame: 12 Weeks

    Baseline and 12 week levels will be compared.

  10. Fasting Glucose

    Time frame: 12 Weeks

    Baseline and 12 week levels will be compared.

  11. High-sensitivity Troponin (hs-TNT)

    Time frame: 12 Weeks

    Baseline and 12 week levels will be compared.

  12. N-terminal of the prohormone brain natriuretic peptide (NTproBNP)

    Time frame: 12 Weeks

    Baseline and 12 week levels will be compared.

  13. C-reactive protein (CRP)

    Time frame: 12 Weeks

    Baseline and 12 week levels will be compared.

  14. Cytokines (IL-1α)

    Time frame: 12 Weeks

    Baseline and 12 week levels (picogram per milileter) will be compared.

  15. Cytokines (IL-1β)

    Time frame: 12 Weeks

    Baseline and 12 week levels (picogram per milileter) will be compared.

  16. Cytokines (IL-4)

    Time frame: 12 Weeks

    Baseline and 12 week levels (picogram per milileter) will be compared.

  17. Cytokines (IL-6)

    Time frame: 12 Weeks

    Baseline and 12 week levels (picogram per milileter) will be compared.

  18. Cytokines (IL-10)

    Time frame: 12 Weeks

    Baseline and 12 week levels (picogram per milileter) will be compared.

  19. Cytokines (IL-17)

    Time frame: 12 Weeks

    Baseline and 12 week levels (picogram per milileter) will be compared.

  20. Cytokines (TNFα)

    Time frame: 12 Weeks

    Baseline and 12 week levels (picogram per milileter) will be compared.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study (EXACT)

Acronym: EXACT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2015
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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